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Children with cerebral palsy have increased muscle tone which often results in decreased active and passive movement at the ankle. While many management strategies exist (including passive stretching, WBV, serial casting, Botox, and surgical tendon lengthening), the utilization of WBV in combination with active exercises and serial casting has not been previously explored. Serial casting is the repeated application of a fiberglass cast (such as that applied to manage stable fractures) on a scheduled (usually weekly basis) to gradually increase the range of motion at a specific joint. It is theorized that combining previously established standard of care practices may result in more rapid clinical change, and hence reduce the need for prolonged intervention; ultimately reducing healthcare costs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Serial Casting Only | Active Comparator |
| |
| Serial Casting + Exercise | Active Comparator |
| |
| Serial Casting + Exercise + WBV | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Other | 2 minutes each exercise with 30 sec break - 4 exercises prior to serial casting |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ankle Dorsiflexion Range of Motion (Goniometer) | Measured with Goniometer in degrees. Knee flexed and knee extended. | Longitudinal through study completion, an average of 6 weeks but upto 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pain (Visual Analogue Scale/Wong-Baker Faces) | Wong-Baker Faces will be used for those unable to provide a visual analogue scale score. Visual Analogue Scale = 0 (no pain) - 10 (worst pain). Wong-Baker Faces = ordinal level categories of pain. Categories = 0 no hurt, 2 hurts little bit, 4 hurts little more, 6 hurts even more, 8 hurst whole lot, 10 hurts worst. On both scales, higher number will be worst outcomes. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse effects | skin breakdown, early removal etc. | Longitudinal through study completion, an average of 6 weeks but upto 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ben Reader, DPT | Contact | 614-722-8374 | ben.reader@nationwidechildrens.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Recruiting | Columbus | Ohio | 43228 | United States |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Whole-Body Vibration | Other | WBV prior to serial casting |
|
| Serial Casting | Other | Serial Casting as provided by standard of care |
|
| Longitudinal through study completion, an average of 6 weeks but upto 12 weeks |
| Length of Casting Episode (Weeks) | Measured in weeks from the date of first serial cast application to date of last cast applied. This will be extracted from the electronic health record. | Longitudinal through study completion, an average of 6 weeks but upto 12 weeks |